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Volver a Desarrollo farmacéutico

Opiniones y comentarios de aprendices correspondientes a Desarrollo farmacéutico por parte de Universidad de California en San Diego

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The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Development course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug development. In this course you will learn the different stages of clinical development as well as the regulatory including but not limited to, an Investigational New Drug Application (IND), New Drug Application (NDA), and product labeling. Additionally you will learn how to Incorporate study design methods for consideration in the design of clinical protocols to assess safety, tolerability, and efficacy in multiple therapeutic areas. In this course you will learn the different phases of clinical development: * Phase 1 or early stage clinical trial are conducted primar­ily to determine how the new drug works in humans, its safety profile and to predict its dosage range. It typically involves between 30 and 100 healthy volunteers. * Phase 2 or Proof of Concept POC studies test for efficacy as well as safety and side effects in a group of between 30 to 200 hundred patients with the disease for which the new drug is being developed. * Phase 3 or late stage clinical development involve much larger group of patients, between a few hundred to thousands, depending on the indication, which will help determine if the new drug can be considered both safe and effective. It will involve control groups using placebo and/or current treatment as a comparison. * Product registration and approval process after a drug is considered safe and effective from Phase 3 trials, it must be authorized in each individual country before it can be marketed. All data gen­erated about the small molecule or biologic is collected and submitted to the regulatory authorities in the US at the FDA, Food and Drug Administration FDA, in Europe the EMA or European Medicines Agency, Japan Ministry of Health and other countries which may require their own national approvals. This course is intended as part 2 of a series: Drug Discovery (, Drug Development and Drug Commercialization ( We would highly recommend that you take the courses in order since it will give you a better understanding on how a drug is discovered in the lab before being tested in clinical trials and then launched in the market place....

Principales revisiones


May 25, 2020

I am really glad to have course offered by california university . Its really helpful for me. And i am thankful to all lecturer, and teachers to explain overall drug development process.\n\nThank you!


Oct 16, 2018

Very well done and informative. I truly appreciate the Drug process in entirety being broken down into sections that are easy to comprehend. It is obvious the speakers were chosen for their knowledge.

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176 - 200 de 231 revisiones para Desarrollo farmacéutico

por Ashwini K

Jul 17, 2017

Course materials are useful, lectures are very easy to understand, some of the video / sound editing is a bit unclear, since you can't see the presenter talk when the slides are being shown. Overall, a great intro to drug development.

por Abram S

Jun 24, 2020

Robust review of the intricacies of the clinical trial process and economic considerations throughout. My only regret is that the data is a bit dated (ending 2012/13) and I am curious to see how things have shifted since then.

por Jonathan P

Apr 03, 2020

The course started well. But the course about Phase 2 was difficult to digest. Even worst, the course about NDA was long, repetitive, with old data (as old as 2003 !) and some regulation from 2009 ! It need a serious update.

por Amjad N

Mar 04, 2019

Overall, I liked this course. There are some improvements I would suggest: > list online resources more clearly > define acronyms and provide better definitions > quizzes need to be longer and slightly more challenging

por Subramanian K

Sep 03, 2017

The drug labeling seminar was not very informative. Both the presenters seemed to be wanting to go one-up on the other with their respective experiences. The entire session was too casual to be labeled as a lecture.

por Elena B

Apr 21, 2018

I would like to see more updated information (i.e. more information on biologicals), current presentation is a bit old (from 2008-2010?)

But it provides good general overview of the clinical development process.

por Urjita J

Jun 01, 2020

Very detailed and conceptually clear information. lectures are very well designed for online learning. Good distribution of the entire drug dev. procedure. Learnt a lot!

por Hussein S

Nov 14, 2017

Provides a good overview on drug development phases and challenges. Some lecturers are from the industry which gives a practical feeling to the whole process.

por Muhamed S E

Aug 13, 2017

Great Course , although i had some hardships understanding some parts and i had to search it online on my own ,, but overall i would recommend it !


Sep 28, 2019

i think you should put the speaker talking videos also in the lec not only the slides this will give more intent to complete the course faster

por Karen O

Jun 30, 2020

Week 3 was the best! Both lecturers had loads of experience in industry, and shared all that knowledge with practical and real-life examples.

por Álvaro S V

Mar 07, 2019

This course gives a wide overview about clinical trials and all the process needed to launch a new drug. I really enjoyed it.

por Komal S

Jun 06, 2020

Very informative content with lot of information about working of pharmaceutical companies during development of drugs.


Jul 30, 2019

Very easy to follow, fun, informal. Downside: speakers often talk in incomplete sentences, use inaudible terms.

por B M T I

Jun 04, 2020

This course was really helpful to me.It helps me to know many unknown things.It was really good.Thanks.

por Nana F

Jun 19, 2019

Very informative and useful course. Thank you very much to everyone who helped this work come to light

por James D

Jan 15, 2019

Great course, but some of the information is becoming outdated due to the course being from 2013

por Lavanya

Feb 25, 2020

Excellent course material could understand the entire scenario of clinical trial as a beginner

por Jan B

Feb 26, 2019

An interesting introduction. It is more of an overview than an actual course. Would do again.


May 07, 2020

happy to learn new things regarding the drug development . thqnks for this great opportunity

por Nadia C

Jan 30, 2020

some of the things was a little bit old - But i liked the content and the concepts

por Yury K

Dec 02, 2019

Need to update the lectures to reflect rapidly changing regulatory issues

por Hiep X N

Aug 05, 2017

Informative course, instructors have a great deal of industry experiences

por abbas a

May 29, 2020

It was very helpful to me,and I learned much better in this quarantine.

por Morongwa

Mar 26, 2020

Thoroughly enjoyed this. Could do with an updating of materials.